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Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.

In this webinar join expert speaker Kelly Thomas, where she will explain the difference between Key Performance Indicators (KPIs) and metrics. Thomas also discusses how to utilize Quality metrics to improve both individual and company performance.

Session Highlights:

Part 1 – Establishing Appropriate Quality Metrics

Understand why metrics are important to both individuals and management

Review common Quality metrics and the associated mathematical equations

Discuss the use of dashboards

Discuss common errors associated with establishing metrics

Part 2 – Driving Quality Culture through appropriate Quality Metrics

Understand that what gets measured will directly impact employee behaviors

Discuss how to ensure Quality metrics will result in the behaviors you want

Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics

Review the contents of the FDA guidance on Quality Metrics

Why You Should Attend:

This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.

Who Should Attend:

Regulatory Affairs professionals

Quality Managers

Quality Engineers

*You may ask your Question directly to our expert during the Q&A session. ** You can buy On-Demand and view it as per your convenience.

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.